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RecruitingLast updated: 27 November 2025

Celestial: This study is recruiting people with relapsed or refractory mantle cell lymphoma to compare how well a combination of targeted therapies work to treat the cancerA Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

Celestial

Clinical summary

Summary

The goal of this study is to compare how well Sonrotoclax targeted therapy plus Zanubrutinib targeted therapy works, compared to Zanubrutinib plus placebo, in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL).

Eligible participants will be randomly allocated to one of two treatment arms.

In the Experimental Arm, participants will receive Sonrotoclax plus Zanubrutinib, both given orally.

In the Placebo Comparator Arm, participants will receive Placebo plus Zanubrutinib, both given orally.

Conditions

This trial is treating people with relapsed or refractory mantle cell lymphoma

Eligibility

Inclusion

  • Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
  • Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
  • Relapsed or refractory disease after the last line of therapy
  • Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
  • Adequate organ function

Exclusion

  • Prior therapy with B-cell lymphoma-2 inhibitor
  • Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi
  • Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
  • Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
  • Known central nervous system involvement by lymphoma
  • Clinically significant cardiovascular disease
  • History of stroke or intracranial hemorrhage within 6 months before first dose of study drug

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT06742996 *
  • BGB-11417-302; 2024-515593-27-00; CTR20250207

Trial sponsor

BeiGene

Scientific Title

A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

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